Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·Attain Stability Quad MRI Lead

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Mirro MRI DR ICD, M

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·WALLSTENT (TIPS, ILIAC, VENOUS)ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·EXPRESS, EXPRESS2 CORONARY STENT SYSTEM (MOMORAIL AND OVER-THE-WIRE)

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·MODEL 1256D META MV CARDIAC PULSE GENERATOR

Occluder, Patent Ductus, Arteriosus

FDA Pre-Market Approval

FDA Class 3 ·AMPLATZER SEPTAL OCCLUDER AND AMPLATZER MULTIFENESTRATED SEPTAL OCCLUDER-CRIBRIFORM

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·PALMAZ-SCHATZ MINICROWN BALLOON-EXPANDABLE STENT WITH DYNASTY

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·DEMA IPGS/ C & T SERIES IPGS

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·CHILLI COOLED RPM CATHETER

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval

FDA Class 3 ·THERAPY DUAL 8/THERAPY & SAFIRE TX ABLATION CATHETERS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·PRODIGY

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval

FDA Class 3 ·EPIC HF/ATLAS + HF FAMILY OF CRT-DS

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·EDWARDS LIFESCIENCES PERIMOUNT AORTIC AND MITRAL BIOPROSTHESES

Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

FDA Pre-Market Approval

FDA Class 3 ·Tendril SDX, ST, STS and OptiSense LV leads

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VENTAK ICD Family

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·HELIOS II ABLATION CATHETER

Pacemaker/Icd/Crt Non-Implanted Components

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC MODELS 2490C CARELINK REMOTE HOME MONITORS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Adapta, Versa, Sensia IPG, Advisa SR MRI IPG, Attesta DR/SR MRI IPG, Sphera DR/SR MRI IPG

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·DEMA IPGS/C & T SERIES IPGS